Folding patterns and loading funnel for improved transcatheter valve loading forces

ABSTRACT

A loading assembly for crimping and loading a prosthetic heart valve into a delivery device includes a loading base, a base funnel, and a compression member. The loading base has a support and a body extending from the support with a recess defined within the body. The recess is configured to receive a substantial portion of the annulus section of the heart valve in an at least partially collapsed condition. The base funnel is configured to be coupled to the loading base and to at least partially collapse the annulus section of the heart valve as it is inserted into the recess in the loading base. The compression member is configured to be coupled to the loading base with the heart valve inserted in the recess for further collapsing the heart valve and loading it into the delivery device.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of the filing date of U.S.Provisional Patent Application No. 62/575,695 filed Oct. 23, 2017, thedisclosure of which is hereby incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION

The present disclosure relates to prosthetic heart valve implantationand, more particularly, to assemblies and methods for loading aself-expanding collapsible heart valve into a delivery device.

Prosthetic heart valves may be formed from biological materials such asharvested bovine valves or pericardium tissue. Such valves are typicallyfitted within a stent, which may be inserted into the heart at theannulus of the compromised native valve to replace the native valve.Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Toperform such insertion procedure, it is often necessary to compress thestent to a reduced diameter for loading into the delivery device.

In the case of prosthetic valves formed from biological materials, thestented valve is preferably preserved in the open condition for storage.The valve may be crimped or its diameter be reduced for loading in thedelivery device, in the operating arena.

Present devices and methods for collapsing a stented valve having anouter cuff may require high forces to load the collapsed valve into thedelivery device due to the larger collapsed size of the valve.Additionally, the outer cuff of the valve may have a tendency to catchon an edge of the delivery device. It would therefore be beneficial toprovide different devices and methods for collapsing a stented heartvalve using apparatus and techniques. Such devices and methods wouldallow for a successful and efficient loading of the heart valve in thedelivery device.

BRIEF SUMMARY OF THE INVENTION

According to an embodiment of the disclosure, a compression member forcollapsing a prosthetic heart valve comprises a first open end with afirst diameter, a second open end with a second diameter smaller thanthe first diameter, a tapered wall decreasing in diameter from the firstopen end to the second open end and having an inner surface, the taperedwall defining an open space adapted to receive the prosthetic heartvalve, and a plurality of protrusions on the inner surface of thetapered wall, the protrusions being adapted to urge portions of an outercuff of the prosthetic heart valve to an interior of the valve as thevalve moves from the first open end toward the second open end.

According to an embodiment of the disclosure, a system for collapsing aprosthetic heart valve comprises a loading base having a body and arecess formed in the body, the recess having a support surface and beingconfigured to receive an annulus section of a prosthetic valve in an atleast partially collapsed condition, a first compression member having afirst open end with a first diameter, a second open end with a seconddiameter smaller than the first diameter, and a tapered wall decreasingin diameter from the first open end to the second open end, and a secondcompression member having a first open end with a third diameter, atubular extension at the first open end, a second open end with a fourthdiameter larger than the third diameter, and a tapered wall decreasingin diameter from the second open end to the tubular extension. The firstcompression member is configured to be positioned against the loadingbase, to receive the annulus section of the prosthetic valve in anexpanded condition and to collapse the annulus section of the prostheticvalve to the at least partially collapsed condition. The secondcompression member is configured to be positioned against the loadingbase at the second open end and to collapse an aortic section and the atleast partially collapsed annulus section of the prosthetic valve.

According to an aspect of the disclosure, a method for loading aprosthetic heart valve into a delivery device comprises at leastpartially collapsing an annulus section of the prosthetic heart valve byinserting through an orifice, positioning the at least partiallycollapsed annulus section in a loading base, collapsing an aorticsection of the prosthetic heart valve, and loading the collapsed aorticsection into the delivery device.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present loading assembly are disclosed hereinwith reference to the drawings, wherein:

FIG. 1 is a perspective view of a distal portion of a prior art deliverydevice;

FIG. 2 is a perspective view of a proximal portion of the deliverydevice of FIG. 1;

FIG. 3 is a perspective view of a prior art embodiment of a collapsibleprosthetic heart valve in an expanded condition;

FIG. 4 is a front view of another embodiment of a collapsible prostheticheart valve in an expanded condition;

FIG. 5 is a perspective view of a loading funnel;

FIG. 6 is a schematic longitudinal cross-section of the loading funnelof FIG. 5, illustrating a coating applied to the inner surface thereof;

FIG. 7 is a perspective view of a loading base for use with the loadingfunnel of FIG. 5;

FIG. 8 illustrates the expanded prosthetic heart valve of FIG. 3assembled onto the loading base of FIG. 7;

FIG. 9 illustrates the loading funnel of FIG. 5 being coupled to theloading base of FIG. 8 for collapsing the prosthetic heart valve of FIG.8;

FIG. 10 illustrates schematically a delivery device coupled to theloading funnel of FIG. 5 for loading the prosthetic heart valve into thedelivery device;

FIG. 11 illustrates schematically bunching of the outer cuff of theprosthetic heart valve of FIG. 4 within the loading funnel while theheart valve is loaded into the delivery device;

FIG. 12 schematically illustrates the bunched outer cuff of FIG. 11engaging an edge of the delivery device;

FIG. 13A is a schematic developed view of the stent and inner cuff of aprosthetic heart valve according to an embodiment of the disclosure,illustrating a folding pattern for the inner cuff;

FIG. 13B is a schematic developed view of the stent and outer cuff of aprosthetic heart valve according to an embodiment of the disclosure,illustrating a folding pattern for the outer cuff;

FIG. 13C is a schematic partial transverse cross-section of the stentand outer cuff in an expanded condition;

FIG. 13D is a schematic partial transverse cross-section of the stentand outer cuff of FIG. 13C in a collapsed condition;

FIG. 14A is a longitudinal cross-section of another embodiment of aloading funnel with a plurality of ridges defined on an inner surface ofthe tapered wall thereof;

FIG. 14B is a schematic longitudinal cross-section of a portion of theloading funnel of FIG. 14A;

FIG. 15A is a perspective view of another embodiment of a loading base;

FIG. 15B illustrates an embodiment of a base funnel coupled to theloading base of FIG. 15A for loading a prosthetic heart valve into theloading base;

FIG. 15C schematically illustrates a top view of the base funnel of FIG.15B;

FIGS. 15D-E are front perspective views showing a process of loading theprosthetic heart valve into the loading base of FIG. 15A using the basefunnel of FIG. 15B;

FIG. 15F is a longitudinal cross-section showing a compression membercoupled to the loading base of FIG. 15A and to a delivery device forloading the prosthetic heart valve into the delivery device;

FIG. 16A is a partial perspective view of an embodiment of the basefunnel with ridges;

FIG. 16B is a partial perspective view of an embodiment of the basefunnel with spring-like fingers; and

FIG. 17 is a flow chart of a method for loading a prosthetic heart valveinto a delivery device using the loading base of FIG. 15A and the basefunnel of FIG. 15B.

DETAILED DESCRIPTION

Embodiments of the presently disclosed loading assemblies and heartvalves are described herein in detail with reference to the drawingfigures, wherein like reference numerals identify similar or identicalelements. In the drawings and in the description which follows, the term“proximal” refers to the end of the loading assembly, or portionthereof, which is closest to the operator during use, while the term“distal” refers to the end of the loading assembly, or portion thereof,which is farthest from the operator during use.

The present disclosure relates to assemblies and methods for loading aself-expanding stent or a collapsible prosthetic heart valve into aminimally invasive delivery device. An exemplary minimally invasivedelivery device 10 is illustrated in FIGS. 1 and 2.

As seen in FIG. 2, the delivery device 10 may include an inner tube 16having a lumen extending therethrough. A hub 14 is mounted on theproximal end of the inner tube 16 and is adapted for connection toanother system or mechanism, such as a handle, a syringe or a mechanismfor displacing a distal sheath 30. Mechanisms for displacing the distalsheath 30 are described in International Patent Application PublicationNo. WO/2009/091509, the entire contents of which are hereby incorporatedherein by reference. A retention ring 12 may also be mounted on theproximal end of the inner tube 16.

As shown in FIG. 1, an outer shaft 20 of the delivery device 10 extendsto a transition member 24, which may have a tapered shape. Thetransition member 24 interconnects a distal end of the outer shaft 20and the distal sheath 30. The distal sheath 30 surrounds a retainingelement 26 and a support shaft 28 and can maintain a prosthetic heartvalve mounted around the support shaft in a collapsed condition. Thesupport shaft 28 is operatively connected to the inner tube 16 and has alumen extending therethrough for receiving a guidewire (not shown). Theretaining element 26 is mounted on the support shaft 28 and isconfigured for supporting an end of a prosthetic heart valve or anyother suitable medical implant. The retaining element 26 may belongitudinally and rotatably fixed relative to the support shaft 28,thereby preventing the cells of the stent from entangling with oneanother during deployment. The distal sheath 30 covers the retainingelement 26 and at least a portion of the support shaft 28 and is movablerelative to the support shaft between a distal position shown in FIG. 1and a proximal position (not shown). An atraumatic tip 32 may beconnected to the distal end of the support shaft 28, and may have atapered shape.

FIG. 3 shows one embodiment of a prosthetic valve 100 designed toreplace a native aortic valve. The valve 100 has a collapsed conditionand an expanded condition and may be formed from a collapsible frameworkor stent 102, with a valve assembly 104 internally connected to thestent. The stent 102 may be formed from any suitable biocompatiblematerial, such as nitinol, and may include an annulus section 106, anaortic section 108, and an intermediate section 110. The aortic section108 may have a larger diameter than the annulus section 106 in theexpanded condition. The intermediate section 110 of the stent 102 islocated between the annulus section 106 and the aortic section 108. Thevalve assembly 104 may include a plurality of leaflets 112 and an innercuff 114 attached to the stent 102. The leaflets 112 and the inner cuff114 may be formed from a biocompatible polymer, from bovine or porcinepericardial tissue, or from other appropriate biocompatible materials.The valve assembly 104 is connected to the stent 102 generally withinthe annulus section 106, but may extend into the intermediate section110. The valve 100 may include tabs or retaining members 118 at spacedpositions around one or both ends of the stent 102. The retainingmembers 118 are typically designed to mate with pockets (not shown) inretaining element 26 to maintain the prosthetic valve 100 in assembledrelationship with the delivery device 10, to minimize longitudinalmovement of the prosthetic valve relative to the delivery device duringunsheathing and resheathing procedures, to help prevent rotation of theprosthetic valve relative to the delivery device as the delivery deviceis advanced to the target site and during deployment, and to maintainthe alignment of the stent cells and prevent them from becoming tangled.

FIG. 4 shows another embodiment of a prosthetic valve 200 designed toreplace a native aortic valve. The valve 200 may be similar inconstruction to the valve 100 described above and may be formed from acollapsible framework or stent 202, with a valve assembly 204 internallyconnected to the stent. The stent 202 may include an annulus section206, an aortic section 208, and an intermediate section 210. The aorticsection 208 may have a larger diameter than the annulus section 206 inthe expanded condition. The intermediate section 210 of the stent 202 islocated between the annulus section 206 and the aortic section 208. Thevalve assembly 204 may include a plurality of leaflets 212 and an innercuff 214 attached to the stent 202. The valve 200 further includes anouter cuff 216 attached to the annulus section 206. More examples ofouter cuffs are described in U.S. Pat. No. 8,808,356, the entire contentof which is hereby incorporated herein by reference. The outer cuff 216promotes sealing with native tissue even where the native tissue isirregular.

The prosthetic valves 100, 200 are preferably stored in their expandedor open condition. As such, the valves 100, 200 may be crimped into acollapsed or reduced diameter condition for surgical implantation. Thecrimping process is preferably conducted in the operating arena by thesurgeon, interventional cardiologist or surgical assistant using aspecialized assembly.

Some exemplary loading assemblies for loading the prosthetic valve 200into a delivery device are described in U.S. Pat. Nos. 9,021,674;8,931,159; and 8,893,370, the entire contents of which are herebyincorporated herein by reference. Referring now to FIGS. 5-7, a loadingassembly according to an embodiment of the present invention isillustrated. The loading assembly generally includes a compressionmember 302 and a loading base 404, both adapted to be coupled to oneanother. The compression member 302 includes a funnel 306 having asubstantially frusto-conical shape with a larger diameter at a first end308 and a smaller diameter at a second end 310. The diameter of thefunnel 306 may decrease either uniformly or non-uniformly from the firstend 308 to the second end 310 to compress the valve 200 as the valve isadvanced through the compression member 302. The compression member 302is preferably made of a substantially rigid material, and may be whollyor partly made of a transparent plastic, such as polycarbonate oracrylic, to allow viewing of the valve 200 during loading.

The compression member 302 may further include an annular rim 314extending from the first end 308 of the funnel 306 for joining thecompression member to the loading base 404 as described below. The rim314 may include a plurality of slots 316 disposed around its outerperiphery. While the drawings show slots 316 that are substantiallyP-shaped, the slots may have any other shapes suitable for securelyholding the compression member 302 to the loading base 404. The rim 314may include four such slots 316, or more or less than four. Regardlessof the number or slots 316, adjacent slots are preferably spacedequidistantly from each other.

The compression member 302 also may include a tubular extension 318projecting from the second end 310 of the funnel 306. The tubularextension 318 has an opening 320 therethrough in communication with theinterior of funnel 306. The opening 320 is sized and shaped to receivethe distal sheath 30 of the delivery device 10 therein. Thecross-section of the tubular extension 318 is preferably substantiallycircular, but may be oblong, oval, elliptical, or polygonal.

FIG. 6 depicts a schematic longitudinal cross-section of the compressionmember 302, showing the inner surface 322 thereof. In an exemplaryembodiment, at least a portion of the inner surface 322 is coated with alayer 324 of a hydrophilic coating (HPC). By way of non-limitingexamples, the HPC may include lubricious coatings available under thetrade mark Serene™ from Surmodics, Inc. of Eden Prairie, Minn. The layer324 serves to reduce friction between the inner surface 322 and thevalve 200, including the stent 202 and the outer cuff 216.

In one embodiment, the entire inner surface 322 of the compressionmember 302 may be coated with the layer 324 of the HPC. In anotherembodiment, only those portions of the inner surface 322 of thecompression member 302 that are envisioned to contact the valve 200 arecoated with the layer 324 of the HPC. For instance, the entire innersurface 323 of the tubular extension 318 is likely to contact the valve200 and therefore may be coated with the HPC layer 324. Likewise, theinner surface 325 of funnel 306 between the first end 308 and the secondend 310 is likely to contact the valve 200 and may be coated entirelywith the HPC layer 324.

In an example, the HPC layer 324 may have a thickness ranging from about500 nanometers (nm) to about 5 micron (μm). In one example, the HPClayer 324 may have a uniform thickness along the inner surface 322. Inanother embodiment, the HPC layer 324 may have varying thicknesses alongthe inner surface 322. For instance, the thickness of the HPC layer 324may be at a minimum proximal to the first end 308 of funnel 306 and mayincrease to a maximum towards the second end 310 of the funnel. Inaddition or alternatively, the HPC layer 324 may be thicker on the innersurface 323 of tubular extension 318 than on the inner surface 325 offunnel 306.

The HPC layer 324 may be applied to the inner surface 322 of thecompression member 302 using any known technique, such as dip coating,spray coating, film coating, chemical vapor deposition or silkscreening. To facilitate dip coating, for example, the outer surface ofthe compression member 302 may be also be coated with an HPC layer. Oncethe HPC layer 324 has been applied to the inner surface 322, the HPClayer may be cured, for example, by heating or using ultraviolet (UV)light, as is known in the art. After the coating and curing processes,additives and other functional materials not bound to the inner surface322 may be rinsed out or otherwise removed.

Referring to FIG. 7, the loading base 404 is preferably made in whole orin part of a substantially rigid material, and includes a body 406having a substantially flat or planar bottom support surface 408 and atop end 410. The body 406 has an outer wall 412 and an aperture 414extending axially through substantially the center of the body. Theaperture 414 is sized to receive at least a portion of the tip 32 of thedelivery device 10 therein. A recess 418 extends downwardly from the topend 410 of the body 406 concentrically with the aperture 414 so as todefine a support surface 420 at a spaced distance from the top end. Therecess 418 has a diameter and a depth defined by the support surface 420sufficient to receive at least a portion of the annulus section 206 ofthe stent 202 in a fully or almost fully expanded condition.

The outer wall 412 of the body 406 does not extend continuously aroundthe body, but rather may be interrupted by a plurality of inwardlycurved indentations 422 which divide the outer wall into a plurality ofwall segments 424, only two of which are shown in FIG. 7. Although FIG.7 depicts a loading base 404 having four indentations 422 evenly spacedaround the periphery of the body 406, it is contemplated that theloading base may be provided with more or less than four suchindentations. Indentations 422 facilitate the grasping of loading base404.

The outer wall segments 424 of the body 406 do not extend all the way tothe top end 410 of the body, but rather terminate at their top ends at acontinuous wall 426 oriented at an oblique angle to the outer wall 412.At their bottom ends, outer wall segments 424 each include a radiallyprojecting supporting plate 428, the bottom surfaces of which aresubstantially coplanar with the bottom support surface 408 of the body406. At least one pin 430 may protrude radially outward from each outerwall segment 424. The pins 430 are preferably spaced a sufficientdistance from supporting plates 428 and sized and shaped to be receivedin the slots 316 of the compression member 302 to join the compressionmember and the loading base 404 together. When joined together, thecompression member 302 and the loading base 404 collectively define apartial loading assembly.

The loading assembly described above may be used to load the collapsibleprosthetic heart valve 200 into a delivery device. As shown in FIG. 8,with the loading base 404 on a flat surface, at least a portion of theannulus section 206 of the stent 202 may be placed within the recess 418of the loading base until the end of the stent contacts support surface420. The compression member 302 may then be placed over the aorticsection 208 of the stent 202 so that the aortic section of the stent ispositioned within the funnel 306, as depicted in FIG. 9. The compressionmember 302 and the loading base 404 may then be pushed together, thetapered inner surface 322 of the funnel 306 gradually compressing thevalve 200 until a portion of the aortic section 208 of the stent 202 isforced into and through the opening 320 of the compression member. Whenthe portion of the aortic section 208 of the stent 202 passes throughthe opening 320 of the compression member 302, the retainers 218 of thestent will protrude through the opening 320 and will be positionedclosely adjacent to one another. At this point, the pins 430 of theloading base 404 will be positioned within the slots 316 of thecompression member 302, and the members may be locked together byrotating the loading base relative to the compression member, such thatthe pins 430 of the loading base slide toward the closed ends of theslots 316 of the compression member.

The portion of the aortic section 208 forced into and through theopening 320 of the compression member 322 may then be received in thedelivery device 10, as illustrated in FIGS. 10-12, so that the retainers218 of the stent 202 are positioned in the pockets in retaining element26. As the aortic section 208 of the valve 200 is pulled through thetubular extension 318, the intermediate section 210 and the annulussection 206 are gradually compressed by the tapered inner surface 322 ofthe funnel 306. Due to frictional resistance, designated by arrow F inFIG. 11, between the tapered inner surface 322 of the funnel 306 and theouter cuff 216, the outer cuff may start bunching up in an aggregationor roll 2162. Such frictional resistance also increases the loadingforce required to pull the valve 200 through the tubular extension 318of the compression member 302 and into the delivery device 10. The roll2162 in the outer cuff 216 may also undesirably engage the edge of thedelivery device 10 as shown in FIG. 12. In one configuration, the HPClayer 324 on the inner surface 322 of the funnel 306 reduces thefrictional resistance between the outer cuff 216 and the inner surface322, thereby reducing the loading force required to the load the valve200 into the delivery device.

While the stent 202 is collapsing, the inner cuff 214 may fold in such amanner as to protrude away, i.e., radially outwardly, from the stent,thereby increasing the undesirable bunching up of the cuff materialand/or the engagement of the cuff material with the edge of the deliverydevice 10. To prevent such an occurrence, in an embodiment, the fabricof the inner cuff 214 may be pre-folded at least partially, such thatwhen the stent 202 is collapsing, the inner cuff will tend to foldtoward the interior, i.e., radially inwardly, of the stent 202. In anexemplary embodiment illustrated in FIG. 13A, the fabric of the innercuff 214 has fold lines 2142 along which the fabric preferably folds.The fold lines 2142 may be formed by applying heat, for example, byironing the fabric in a folded condition in which the fold lines facetoward the radial center of the stent 202. In another example, the foldlines 2142 may be formed by applying force and folding the fabric priorto attaching the inner cuff 214 to the stent 202. Likewise, the fabricof the outer cuff 216 may be pre-folded to form fold lines 2166, asillustrated in FIGS. 13B-D, such that when the stent 202 is collapsing,the fabric of the outer cuff 216 will tend to fold radially inwardbetween the struts of the stent. The fold lines 2166 may be formed inthe same manner or manners as the fold lines 2142.

FIG. 13C illustrates, in partial transverse cross-section, two adjacentstruts 2022, 2024 of the stent 202 at a first distance d₁ from oneanother when the stent is in an expanded condition, and a segment 2164of the fabric of the outer cuff 216 on the exterior of the stent. Whenthe stent 202 is collapsing, the adjacent struts 2022, 2024 move closerto one another so that there is a distance d₂ between them, the distanced₂ being smaller than the distance d₁. The fabric segment 2164 foldsbetween adjacent struts 2022, 2024 toward the interior of the stent 202,i.e., radially inwardly. Such a folding pattern for the outer cuff 216may prevent or reduce the formation of the roll 2162.

In addition, or as an alternative, to the pre-folding of the fabrics ofthe inner cuff 214 and the outer cuff 216, one or more components of theloading assembly may be configured to cause the fabrics of the innercuff and the outer cuff to fold radially inwardly. For instance, in anembodiment illustrated in FIGS. 14A-14B, the funnel 1406 of thecompression member 1402 may include a plurality of protrusions 1408defined on its inner surface 1425. As the valve 200 is pulled throughthe tubular extension 1428 of the compression member 1402 and the stent202 is collapsing, the plurality of protrusions 1408 urge the fabrics ofthe outer cuff 216 and the inner cuff 214 radially inwardly betweenadjacent struts of the stent and into the stent interior. As the fabricof the outer cuff 216 is pushed radially inwardly by the plurality ofprotrusions 1408, the aggregation or rolling of the fabric, such as theformation of roll 2162, may be avoided. In one example, the compressionmember 1402 may include an HPC layer 1424 on its inner surface 1422. TheHPC layer 1424 may be similar to the HPC layer 324 described above, andmay contribute to preventing the undesirable aggregation or rolling ofthe fabric of the outer cuff 216.

The plurality of protrusions 1408 may be placed circumferentially on theinner surface 1425 of the funnel 1406. In an example, the protrusions1408 may be uniformly spaced apart from one another. For example, thespacing between two adjacent protrusions 1408 may be between about 0.05inches (in.) and about 0.25 in. Preferably, the spacing between theprotrusions 1408 is such that the protrusions align with the center ofthe stent cells in an expanded condition of the stent, enabling theprotrusions to push the fabrics of the inner cuff 214 and the outer cuff216 through the stent cells to the interior of the stent. Theprotrusions 1408 may have a length between about 0.05 in. and about 0.5in., a thickness from the inner surface 1425 between about 0.02 in. andabout 0.1 in., and a width between about 0.02 in. and about 0.05 in. Inan exemplary embodiment, all of the protrusions 1408 may be uniformlydimensioned. In another embodiment, the dimensions of the protrusions1408 may vary. For instance, one of the protrusions 1408 may have afirst set of dimensions, while protrusions adjacent to the oneprotrusion may have at least one dimension that differs from the firstset. Such a configuration may aid in the folding of the inner cuff 214and the outer cuff 216 within the stent cells of different sizes orlocations within the stent. In yet another embodiment, a first subset ofthe protrusions 1408 may have a first set of dimensions, while subsetsof protrusions 1408 adjacent the first subset may have at least onedimension that is different from those of the first set.

The plurality of protrusions 1408 may be formed integrally with thecompression member 1402, for example, using injection moldingtechniques. Alternatively, the protrusions 1408 may be formed separatelyfrom the compression member, and may be assembled to the inner surface1425 of the funnel 1406 by any known technique, including a snap orpress fit arrangement, fasteners, adhesive, ultrasonic welding and thelike.

In one embodiment, the plurality of protrusions 1408 may be provided atabout a longitudinal mid-point of the inner surface 1425 of the funnel1406. In another embodiment, the plurality of protrusions 1408 may beprovided proximate the tubular extension 1428. In yet anotherembodiment, the funnel 1406 may include a first series of protrusions1408 at about the longitudinal mid-point of the inner surface 1425 ofthe funnel 1406 and a second series of ridges 1408 proximate the tubularextension 1428. The first and second series of ridges 1408 may alternatearound the circumference of the funnel 1406.

Referring now to FIGS. 15A-15F, a further embodiment of a loadingassembly is described. The loading assembly includes a loading base1500, a base funnel or a first compression member 1600 and a loadingfunnel or a second compression member 1400 that may be similar to thecompression members 302 or 1402 described above. The loading base 1500may be generally similar to the loading base 404 with a few differences.For instance, the recess 418 of the loading base 404 is generally sizedto receive the annulus section 206 of the valve 200 in a fully expandedcondition. In contrast, the loading base 1500 includes a recess 1518having a size smaller than the size of a fully expanded annulus section206 of the heart valve 200. More particularly, the recess 1518 has aninner diameter d_(r) smaller than the diameter of the fully expandedannulus section 206, such that the recess receives the annulus sectionof the valve 200 in an at least partially collapsed condition. In anexample, the inner diameter d_(r) may be about 50% of the diameter ofthe fully expanded annulus section 206. The recess 1518 of the loadingbase 1500 is configured to receive a substantial portion of the annulussection 206 of the valve 200. To accommodate the annulus section 206,the recess 1518 has a height h_(r) almost corresponding to the height ofthe annulus section. In an example, the recess 1518 of the loading base1500 may have a height sufficient to receive from about 70% to about 90%of the height of the annulus section 206. Thus, when the annulus section206 of the valve 200 is received in the loading base 1500, the stent 202is at least partially collapsed and, as described in detail below, thefabrics of the inner cuff 214 and the outer cuff 216 are folded inwardlyinto the stent 206.

The base funnel 1600 is configured to be coupled to the loading base1500 for inserting the annulus section 206 of the heart valve 200 intothe recess 1518 of the loading base 1500, as shown in FIG. 15B. The basefunnel 1600 has a first open end 1608, a second open end 1610 and atapered wall 1612 extending between the first and second open ends. Thefirst end 1608 of the base funnel 1600 has a diameter sized to receivethe annulus section 206 of the valve 200 in a fully expanded condition.The second end 1610 of the base funnel 1600 has a diameter that isslightly smaller than or the same as the diameter of the recess 1518,i.e., the outer diameter of the second end 1610 is slightly smaller thanor the same as the inner diameter d_(r). The base funnel 1600 may becoupled to the loading base 1500 in a variety of ways, such as a snapfit, a press fit, or a screw mechanism. With the base funnel 1600coupled to the loading base 1500, the annulus section 206 of the heartvalve 200 may be pushed through the base funnel, as shown in FIG. 15D,whereupon the annulus section at least partially collapses and isreceived in recess 1518. As the stent 202 is partially collapsed in theannulus section 206, the fabrics of the inner cuff 214 and the outercuff 216 may be folded inwardly between the struts of the stent. In anexemplary embodiment, the base funnel 1600 is configured with alongitudinal split 1602, shown in FIG. 15C, that enables two portions ofthe base funnel to be moved relative to one another. After the annulussection 206 has been inserted through the base funnel 1600 and into therecess 1518, the portions of the base funnel may be opened up along thesplit 1602 and removed from the loading base 1500, as shown in FIG. 15E.In another embodiment, the base funnel 1600 may have two longitudinalsplits 1602 diametrically opposite one another such that the twoportions of the base funnel may be completely separated from oneanother.

The base funnel 1600 may include a plurality of ridges 1606 as shown inFIGS. 15C, 16A. Ridges 1606 may be similar to the ridges 1406 describedabove, and are configured to urge the fabrics of the inner cuff 214 andthe outer cuff 216 to fold radially inwardly into the interior of thestent 202. In another embodiment, illustrated in FIG. 16B, a base funnel1700 may include a plurality of spring-like fingers 1706 that protrudeinwardly from the tapered wall of the base funnel. The spring-likefingers 1706 are configured to urge the fabrics of the inner cuff 214and the outer cuff 216 radially inwardly into the interior of the stent202, between adjacent struts thereof, in a manner similar to that of theridges 1606. However, if one or more struts of the stent 202 engage aspring-like finger 1706, the finger will yield to the strut and getpushed radially outwardly toward and into the tapered wall of the funnel1700. As a result, damage to the stent 202 may be prevented orminimized.

FIG. 15F shows the loading base 1500 in an inverted orientation andcoupled to a compression member 302, 1402 for loading the valve 200 intothe delivery device 10 as described above. More particularly, the secondopen end of the compression member 1402 is placed over the loading base1500 and over the aortic section 208 of at least partially collapsedheart valve 200. The at least partially collapsed annulus section 206 ofthe heart valve 200 resides in the recess 1518, whereas the aorticsection 208 faces the tubular extension 1428 of the compression member1402. As the compression member 1402 is moved closer to the loading base1500, the compression member begins to compress the aortic section 208.The compressed aortic section 208 is then pulled through the tubularextension 1428, thereby further compressing the heart valve 200. As theannulus section 206 engages the compression member 1402, it may befurther compressed, if it is not completely compressed in the recess1518. This additional compression may be achieved by forming the tubularextension 1428 with an inner diameter that is smaller than the innerdiameter d_(r) of the recess 1518. Since the annulus section 206 of thevalve 200 is at least partially collapsed with the fabrics of the innercuff 214 and the outer cuff 216 folded inwardly, formation of a fabricbunch or roll, such as roll 2162, may be prevented. The aortic section208 and the annulus section 206 are compressed tightly as they passthrough the tubular extension 1428 and the compressed heart valve 200may then be loaded into the delivery device 10.

FIG. 17 illustrates a flow chart of a method for loading the heart valve200 into the delivery device 10 using the loading base 1500, the basefunnel 1600 and the compression member 1402. At step 1810, the basefunnel 1600 is coupled to the loading base 1500 such that the secondopen end 1610 of the base funnel is received within with the recess 1518of the loading base. At step 1820, the annulus section 206 of the heartvalve 200 is inserted into the base funnel 1600. As the heart valve 200is pushed into the base funnel 1600, the annulus section 206 is at leastpartially collapsed by the tapered inner surface of the base funneluntil it passes through the narrow second open end 1610 and is receivedwithin the recess 1518 of the loading base 1500. After the annulussection 206 has been received in the recess 1518, the base funnel 1600is removed from the loading base 1500, at step 1830, leaving the heartvalve 200 in the loading base 1500. At step 1840, the compression member1402 is coupled to the loading base 1500 with the aortic section 208 ofthe heart valve 200 facing the tubular extension 1428. The coupling ofthe compression member 1402 to the loading base 1500 further collapsesthe heart valve 200, particularly at its aortic section 208. The heartvalve 200 is then loaded into the delivery device 10 as described abovewith reference to FIGS. 9 and 10. Since the annulus section 206 of theheart valve 200 is at least partially collapsed, the fabrics of theinner cuff 214 and the outer cuff 216 are held between the adjacentstruts 202 and do not interfere or create resistance when the heartvalve is loaded into the delivery device 10.

To summarize the foregoing, a first aspect of the disclosure describes acompression member for collapsing a prosthetic heart valve. Thecompression member includes:

a first open end with a first diameter;

a second open end with a second diameter less than the first diameter;

a tapered wall decreasing in diameter from the first open end to thesecond open end and having an inner surface, the tapered wall definingan open space adapted to receive the prosthetic heart valve; and

a plurality of protrusions on the inner surface of the tapered wall, theprotrusions being adapted to urge portions of an outer cuff of theprosthetic heart valve to an interior of the valve as the valve movesfrom the first open end toward the second open end; and/or

the inner surface may include a layer of a hydrophilic coating; and/or

each of the protrusions is a spring-like finger; and/or

each of the spring-like fingers is deflectable toward the inner surface;and/or

the inner surface includes a layer of a hydrophilic coating.

A second aspect of the disclosure describes a system for collapsing aprosthetic heart valve. The system includes:

a loading base having a body and a recess formed in the body, the recesshaving a support surface and being configured to receive an annulussection of a prosthetic valve in an at least partially collapsedcondition;

a first compression member having a first open end with a firstdiameter, a second open end with a second diameter less than the firstdiameter, and a tapered wall decreasing in diameter from the first openend to the second open end, the first compression member beingconfigured to be positioned against the loading base, to receive theannulus section of the prosthetic valve in an expanded condition and tocollapse the annulus section of the prosthetic valve to the at leastpartially collapsed condition; and

a second compression member having a first open end with a thirddiameter, a tubular extension at the first open end, a second open endwith a fourth diameter larger than the third diameter, and a taperedwall decreasing in diameter from the second open end to the tubularextension, the second compression member being configured to bepositioned against the loading base at the second open end and tocollapse an aortic section and the at least partially collapsed annulussection of the prosthetic valve; and/or

a prosthetic heart valve having an expanded condition, a collapsedcondition, a stent formed of a plurality of struts, an inner cuff and anouter cuff, a fabric of at least one of the inner cuff and the outercuff in the expanded condition of the prosthetic heart valve having foldlines such that when the prosthetic heart valve is moved to thecollapsed condition, the fabric is folded along the fold lines radiallyinwardly between adjacent ones of the struts into an interior of thestent; and/or

at least one of the first compression member and the second compressionmember includes a layer of a hydrophilic coating on an inner surfacethereof; and/or

the tapered wall of at least one of the first compression member and thesecond compression member includes a plurality of protrusions extendingradially inwardly, the plurality of protrusions being configured to urgeportions of an outer cuff of the prosthetic heart valve to the interiorof the valve; and/or

each of the protrusions is a spring-like finger; and/or

the first compression member includes a split extending from the firstopen end to the second open end, the split enabling two portions of thefirst compression member to be moved relative to one another.

A third aspect of the disclosure describes a method for loading aprosthetic heart valve into a delivery device. The method comprises:

at least partially collapsing an annulus section of the prosthetic heartvalve by inserting through an orifice;

positioning the at least partially collapsed annulus section in aloading base;

collapsing an aortic section of the prosthetic heart valve; and

loading the collapsed aortic section into the delivery device; and/or

further collapsing the annulus section to load the prosthetic heartvalve into the delivery device; and/or

the step of at least partially collapsing the annulus section of theprosthetic heart valve includes positioning a first compression memberagainst the loading base and passing the annulus section of theprosthetic heart valve through the first compression member; and/or

moving the first compression member away from the loading base afterpositioning the at least partially collapsed annulus section in theloading base; and/or

the step of collapsing the aortic section of the prosthetic heart valveincludes positioning a second compression member against the loadingbase and passing the aortic section of the prosthetic heart valvethrough the second compression member; and/or

the loading step includes loading the prosthetic heart valve into thedelivery device through the second compression member.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

The invention claimed is:
 1. A compression member for collapsing aprosthetic heart valve, the compression member comprising: a first openend with a first diameter; a second open end with a second diameter lessthan the first diameter; a tapered wall decreasing in diameter from thefirst open end to the second open end and having an inner surface, thetapered wall defining an open space adapted to receive the prostheticheart valve; and a plurality of protrusions on the inner surface of thetapered wall, the protrusions being adapted to urge portions of an outercuff of the prosthetic heart valve to an interior of the valve as thevalve moves from the first open end toward the second open end, whereineach of the plurality of protrusions extends parallel to a plane passingthrough a central axis of the compression member.
 2. The compressionmember according to claim 1, wherein the inner surface includes a layerof a hydrophilic coating.
 3. The compression member according to claim1, wherein each of the protrusions is a spring type finger.
 4. Thecompression member according to claim 3, wherein each of the spring typefingers is deflectable toward the inner surface.
 5. The compressionmember according to claim 3, wherein the inner surface includes a layerof a hydrophilic coating.
 6. A system for collapsing a prosthetic heartvalve, the system comprising: a loading base having a body and a recessformed in the body, the recess having a support surface and beingconfigured to receive an annulus section of a prosthetic valve in an atleast partially collapsed condition; a first compression member having afirst open end with a first diameter, a second open end with a seconddiameter less than the first diameter, and a tapered wall decreasing indiameter from the first open end to the second open end, the firstcompression member being configured to be positioned against the loadingbase, to receive the annulus section of the prosthetic valve in anexpanded condition and to collapse the annulus section of the prostheticvalve to the at least partially collapsed condition; and a secondcompression member having a first open end with a third diameter, atubular extension at the first open end, a second open end with a fourthdiameter larger than the third diameter, and a tapered wall decreasingin diameter from the second open end to the tubular extension, thesecond compression member being configured to be positioned against theloading base at the second open end and to collapse an aortic sectionand the at least partially collapsed annulus section of the prostheticvalve.
 7. The system according to claim 6, further comprising aprosthetic heart valve having an expanded condition, a collapsedcondition, a stent formed of a plurality of struts, an inner cuff and anouter cuff, a fabric of at least one of the inner cuff and the outercuff in the expanded condition of the prosthetic heart valve having foldlines such that when the prosthetic heart valve is moved to thecollapsed condition, the fabric is folded along the fold lines radiallyinwardly between adjacent ones of the struts into an interior of thestent.
 8. The system according to claim 6, wherein at least one of thefirst compression member and the second compression member includes alayer of a hydrophilic coating on an inner surface thereof.
 9. Thesystem according to claim 6, wherein the tapered wall of at least one ofthe first compression member and the second compression member includesa plurality of protrusions extending radially inwardly, the plurality ofprotrusions being configured to urge portions of an outer cuff of theprosthetic heart valve to the interior of the valve.
 10. The systemaccording to claim 9, wherein each of the protrusions is a spring-likefinger.
 11. The system according to claim 6, wherein the firstcompression member includes a split extending from the first open end tothe second open end, the split enabling two portions of the firstcompression member to be moved relative to one another.
 12. Acompression member for collapsing a prosthetic heart valve, thecompression member comprising: a first open end with a first diameter; asecond open end with a second diameter less than the first diameter; atapered wall decreasing in diameter from the first open end to thesecond open end and having an inner surface, the tapered wall definingan open space adapted to receive the prosthetic heart valve; and aplurality of protrusions on the inner surface of the tapered wall, theprotrusions being adapted to urge portions of an outer cuff of theprosthetic heart valve to an interior of the valve as the valve movesfrom the first open end toward the second open end, wherein the innersurface includes a layer of a hydrophilic coating, the layer having athickness ranging from about 500 nanometers to about 5 microns.